Gensulin N - Instructions For Use, Indications, Doses, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Gensulin N

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Gensulin N is a genetically engineered medium-acting human insulin designed to regulate glucose metabolism.

Release form and composition

The dosage form of Gensulin N is a suspension for subcutaneous (s / c) administration: a white suspension, at rest separating into a white precipitate and a colorless or almost colorless supernatant; with gentle shaking, the precipitate is quickly resuspended (3 ml in cartridges, 5 cartridges in cell contour packs, 1 package in a cardboard box; 10 ml in transparent colorless glass bottles, 1 bottle in a cardboard box).

Composition for 1 ml of suspension:

• active substance: recombinant human insulin-isophane - 100 IU;
• auxiliary components: phenol, glycerol, metacresol, protamine sulfate, sodium hydrogen phosphate dodecahydrate, zinc oxide, hydrochloric acid, water for injection.

Indications for use

Gensulin N is recommended for use in type 1 diabetes mellitus, as well as type 2 diabetes mellitus in the stage of resistance to hypoglycemic agents for oral administration, partial resistance to these drugs (in the case of combined treatment) and intercurrent diseases.

Contraindications

Gensulin N is contraindicated in patients with hypoglycemia and hypersensitivity to any of the components of the drug.

Method of administration and dosage

The Gensulin N suspension is intended for subcutaneous administration.

The doctor determines the dose of the drug in each case based on blood glucose levels, and taking into account the individual characteristics of the patient. The average daily dose varies in the range of 0.5-1 IU per 1 kg of patient weight.

It is preferable to inject into the thigh; it is also allowed to inject the drug into the buttock, anterior abdominal wall or deltoid muscle of the shoulder. The injection sites within the anatomical region must be changed to avoid lipodystrophy.

When stirring the suspension, the vial or cartridge should not be shaken vigorously, as this can cause the formation of foam, which makes it difficult to set the dose correctly. The appearance of the drug in vials and cartridges should be regularly checked, if there are flakes in the suspension or white particles are observed adhering to the bottom / walls of the vial or cartridge, creating the effect of frost, it cannot be used.

The temperature of the injected suspension should be at room temperature.

Injection procedure:

1. At the injection site, disinfect the skin with alcohol.
2. Use two fingers to fold a piece of skin.
3. Insert the needle at an angle of about 45 ° into the base of the fold and inject insulin under the skin.
4. After injection, do not remove the needle for at least 6 seconds to make sure that the drug is completely injected.
5. If blood appears at the injection site after removing the needle, press it lightly with your finger.
6. The injection sites must be changed.

Gensulin N is used as a monotherapy drug and as part of complex treatment with short-acting insulin (Gensulin R).

The patient should be familiarized with the techniques for using the drug depending on the baseline conditions.

Application of the suspension in vials

Using one type of insulin:

1. Remove the aluminum protective cap from the bottle.
2. Disinfect the rubber membrane on the vial.
3. Draw air into the syringe in a volume corresponding to the required dose of insulin and introduce air into the vial.
4. Turn the vial with the syringe inserted upside down and draw the required dose of insulin into it.
5. Remove the needle from the vial, remove air from the syringe, check if the required insulin dose is correct.
6. Inject.

The use of two types of insulin:

1. Remove aluminum protective caps from vials.
2. Disinfect the rubber membranes on the vials.
3. Immediately before the set, roll the bottle of insulin of medium duration (long) action in the form of a suspension between the palms until the sediment is evenly distributed and a white cloudy suspension is formed.
4. Draw air into the syringe in a volume corresponding to the required dose of long-acting insulin, introduce air into the vial with the suspension, and then remove the needle.
5. Draw air into the syringe in a volume corresponding to the required dose of short-acting insulin, inject air into the vial with insulin in the form of a clear solution, turn the vial with the syringe upside down and dial the required dose.
6. Remove the needle from the vial, remove air from the syringe, check if the required insulin dose is correct.
7. Insert the needle into the suspension vial, turn the syringe vial upside down and collect the required long-acting insulin dose.
8. Remove the needle from the vial, remove air from the syringe, check that the total insulin dose is correct.
9. Inject.

It is important to always draw insulins in the sequence described above.

Application of suspension in cartridges

Cartridges with Gensulin N are intended for use only with Owen Mumford syringe pens. The requirements set forth in the instructions for use of the syringe pen for the administration of insulin should be observed.

Before using Gensulin N, the cartridge must be inspected and made sure that there is no damage (chips, cracks), if they are present, the cartridge cannot be used. After installing the cartridge in the syringe pen, a colored strip should be visible in the holder window.

Before installing the cartridge in the pen syringe, it should be turned up and down so that the small glass ball inside mixes the suspension. The turning procedure is repeated at least 10 times until a white and evenly cloudy suspension is formed. The injection is then given immediately.

If the cartridge is installed in the pen-syringe earlier, stirring of the suspension is carried out for the entire system (at least 10 times) and repeated before each injection.

At the end of the injection, the needle must be left under the skin for at least 6 seconds, and the button must be held down until the needle is completely removed from the skin. This will ensure the correct dose is delivered and limit the possibility of blood / lymph getting into the needle or insulin cartridge.

The cartridge with Gensulin N is intended solely for individual single use and cannot be refilled.

Side effects

• consequences of influence on carbohydrate metabolism: hypoglycemic conditions - headache, pale skin, palpitations, increased sweating, tremors, agitation, hunger, paresthesia in the mouth; as a result of severe hypoglycemia, hypoglycemic coma may develop;
• hypersensitivity reactions: rarely - skin rashes, Quincke's edema; extremely rare - anaphylactic shock;
• reactions at the injection site: swelling and itching, hyperemia; in case of prolonged use - lipodystrophy at the injection site;
• other: edema, transient refractive errors (usually at the beginning of the course of therapy).

An overdose symptom may be the development of hypoglycemia. For the treatment of a mild condition, it is recommended to ingest sugar or foods rich in carbohydrates. Patients with diabetes should always carry sugar, sweets, cookies or sugary drinks with them.

In the case of a significant decrease in glucose concentration, when the patient loses consciousness, a 40% dextrose solution is administered intravenously, intramuscularly, intravenously or subcutaneously - glucagon. After regaining consciousness, it is recommended to eat a carbohydrate-rich diet to prevent hypoglycemia from recurring.

special instructions

It is forbidden to use Gensulin N if the suspension does not become white and evenly cloudy after shaking.

Insulin therapy requires constant monitoring of blood glucose levels. Such monitoring is necessary, since in addition to an overdose of insulin, the causes of hypoglycemia can be: skipping meals, changing the drug, diarrhea, vomiting, increased physical activity, reducing the need for insulin diseases (renal / liver failure, hypofunction of the adrenal cortex, thyroid gland or pituitary gland), change injection sites, drug interactions with other drugs.

Inappropriate dosing or intervals between insulin injections, especially in patients with type 1 diabetes mellitus, can cause hyperglycemia. Usually, the initial symptoms of hyperglycemia develop gradually, over several hours or days. Dry mouth, thirst, nausea, vomiting, dizziness, redness and dryness of the skin, loss of appetite, the smell of acetone in the exhaled air, and increased urination appear. If treatment is not carried out, then in type 1 diabetes mellitus, hyperglycemia can lead to the development of a life-threatening condition - diabetic ketoacidosis.

Correction of the insulin dose is required for hypopituitarism, thyroid dysfunction, Addison's disease, hepatic / renal failure, as well as in elderly patients over the age of 65 years.

The need to adjust the dose of insulin may also be required when the intensity of physical activity or changes in the usual diet.

The need for insulin is increased by concomitant diseases, especially of an infectious nature, and conditions accompanied by fever.

The transition from one type of insulin to another must also be carried out by monitoring blood glucose levels.

It is important to consider that the use of insulin decreases the patient's tolerance to alcohol.

It is not recommended to use Gensulin N in insulin pumps due to the possibility of suspension precipitation in some catheters.

Due to hypoglycemia, it is possible that the patient's ability to concentrate and reduce the rate of psychophysical reaction may be impaired, which can increase the risk when driving and / or working with other complex mechanisms.

Drug interactions

• oral hypoglycemic drugs, monoamine oxidase (MAO) inhibitors, angiotensin-converting enzyme (ACE) inhibitors, non-selective β-adrenergic blockers, carbonic anhydrase inhibitors, bromocriptine, sulfonamides, tetracyclines, octreotide, anabolic steroids, pyrocetamide, pyroxylamide lithium preparations, fenfluramine, ethanol-containing preparations: enhance the hypoglycemic effect of insulin;
• thiazide diuretics, glucocorticosteroids (GCS), oral contraceptives, thyroid hormones, sympathomimetics, heparin, tricyclic antidepressants, clonidine, danazol, diazoxide, calcium channel blockers, phenytoin, morphine, nicotine: weaken the hypulinoglycemic effect;
• reserpine and salicylate: can both weaken and enhance the effect of insulin.

Analogs

Analogs of Gensulin N are: Biosulin N, Vozulim N, Insuman Bazal GT, Insuran NPKh, Protamine-insulin ChS, Protafan NM, Protafan NM Penfill, Rinsulin NPH, Rosinsulin S, Humodar B 100 Rec.

Terms and conditions of storage

Store at 2–8 ° C, the suspension must not be frozen. Keep out of the reach of children.

Shelf life is 2 years.

After opening the original packaging, the shelf life in a dark place at temperatures up to 25 ° C is 4 weeks.

Terms of dispensing from pharmacies

Dispensed by prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!